Our co-pending Indian Patent application vide No.451/MAS/2002 disclosed the novel crystalline forms of Sumatriptan succinate, which are designated as Form-I and Form-II along with their process for preparation. These are also disclosed in PCT Application US03/19004 filed on Jun. 12, 2003.
Another co-pending Indian Patent application vide No.452/MAS/2002 described the purification process for obtaining highly pure Sumatriptan. A process for obtaining highly pure sumatriptan is also disclosed in PCT Application US03/19004 filed on Jun. 12, 2003.
It has been disclosed earlier that the amorphous forms in a number of drugs exhibit different dissolution characteristics and in some cases different bioavailability patterns compared to crystalline forms. For some therapeutic indications one bioavailabilility pattern may be favored over another. An amorphous form of Cefuroxime axetil is a good example for exhibiting higher bioavailability than the crystalline form. During our laboratory experimentation as a part of process development, an amorphous form of Sumatriptan succinate resulted while crystallizing the Sumatriptan in different solvents.
The present invention provides an amorphous form of Sumatriptan succinate. The invention also provides a process for the preparation of an amorphous form of Sumatriptan succinate.
The amorphous form of Sumatriptan succinate of the present invention is characterized by X-ray powder diffractogram, having broad peaks.
The amorphous form of Sumatriptan obtained in the present invention is free flowing, non-hydrated, non-solvated and thermally stable solid.
The process for the preparation of the amorphous form of the present invention is simple, eco-friendly and easily scalable.
U.S. Pat. Nos. 4,816,470; and 5,037,845 are related to the present field of the invention and both of these patents are hereby incorporated by reference in their entirety.